Perioperative Colloid vs Crystalloid in Patients Undergoing Colorectal Surgery (KoKris)

University Hospital Muenster

Status and phase: Terminated; Phase 4

Conditions: Surgery, Colorectal

Treatments: Drug: balanced 6% hydroxyethylstarch 130/0.4; Drug: balanced crystalloid

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01303250

2009-017595-25 (EudraCT Number)

UKM09_0031

04-AnIt-09 (Other Identifier)

Details and patient eligibility

About

The primary purpose of this study is to determine the effect of a balanced 6%hydroxyethyl starch 130/0.4 vs. a balanced crystalloid in colorectal surgery. The intraoperative fluid management will be given to optimize the stroke volume variation <= 12%.

The investigators hypothesize that patients in the intervention group will need less fluid administration be optimal hemodynamic stabilized.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients undergoing elective colorectal surgery
• minimum age 18 years
• informed consent

Exclusion criteria

• patients with severe cardiomyopathy or severe heart failure
• history of coagulation disorders
• intracranial hemorrhage
• patients with severe cardiovascular or respiratory disorders
• renal insufficiency
• severe liver diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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31 participants in 2 patient groups

Group 1

Experimental group

Description:

A balanced hydroxyethyl starch 130/0.4 will be used

Treatment:

Drug: balanced 6% hydroxyethylstarch 130/0.4

Group 2

Active Comparator group

Description:

A balanced crystalloid will be used

Treatment:

Drug: balanced crystalloid